BREXIN

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These reactions may also consist of respiratory tract reactivity comprising of asthma, aggravated asthma, bronchospasm or dyspnoea. There may be other non-specific allergic reactions and anaphylaxis. Other hypersensitivity reactions such as vasculitis and serum sickness have been rarely reported. Dermatological Reaction Photosensitivity reactions occur infrequently. Renal Rarely, NSAIDs may cause interstitial nephritis, glomerulo-nephritis, nephrotic syndrome and renal failure. Haematological Reactions Decreases in haemoglobin and haematocrit in the absence of obvious gastrointestinal bleeding have occurred and anaemia has been reported, as have thrombocytopenia, non-thrombocytopenic purpura (Henoch-Schoenlein), leucopenia and eosinophilia. There are rare reports of aplastic anaemia, haemolytic anaemia and epistaxis. Hepatic Changes in various liver function parameters have been seen with piroxicam and, as with other NSAIDs, some patients may show an increase in serum transaminase concentration during piroxicam treatment; also, severe hepatic reactions, including jaundice and cases of fatal hepatitis have also occurred. Even though such events are rare, where abnormal liver function tests persist or worsen or clinical signs consistent with liver disease develop, or there are systemic manifestations (such as a rash or eosinophilia), treatment should be discontinued. Cardiovascular Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment. Equally, elderly, frail or debilitated patients require careful supervision because they may tolerate side effects less well; the elderly require caution since they are more likely to have impaired renal, hepatic or cardiac function. Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Neurological and Special Senses CNS effects including dizziness, headache, somnolence, insomnia, depression, nervousness, hallucinations, mood alterations, dream abnormalities, mental confusion, paraesthesias, vertigo, visual disturbances, optic neuritis, tinnitus, malaise, fatigue and drowsiness have all been reported. Palpitations, metabolic abnormalities such as hypoglycaemia, weight increase or decrease and anecdotal cases of positive ANA or hearing impairment have all been reported. 4.9 Overdose Symptoms The most likely symptoms of overdose are headache, vomiting, drowsiness, dizziness and fainting. Management In the event of an overdose with Brexin, supportive and symptomatic management is necessary and may include gastric lavage and the use of oral activated charcoal to reduce absorption of piroxicam. The correction of severe electrolyte abnormalities may need to be considered. 5. Pharmacological Properties 5.1 Pharmacodynamic Properties Brexin is an inclusion complex of piroxicam and βeta-cyclodextrin (piroxicam βetadex). It is a non-steroidal anti-inflammatory drug. The faster dissolution characteristics of piroxicam βetadex (about 100 % in 10 minutes) with respect to piroxicam alone, results in a quicker absorption of the active ingredient and promotes a more rapid onset of analgesic action (see Pharmacokinetics). 5.2 Pharmacokinetic Properties As a NSAID, piroxicam is well absorbed after oral administration and is extensively metabolised by the liver with elimination occurring via the kidneys. The drug has a plasma half-life of about 50 hours with the maintenance of plasma levels for up to 24 hours. Steady state levels are reached in 7 to 12 days and maintained with little change for up to a year of treatment. The absorption of piroxicam from piroxicam βetadex is more rapid than that of piroxicam alone, so that the time taken to reach the maximum plasma concentration (Tmax), is much shorter; clinically this is reflected by a more rapid onset of acute analgesia after single doses.
Page 1 and 2: רשואו קדבנ ונכותו ת
Page 3 and 4: NSAIDs, including piroxicam, can ca
Page 5 and 6: Other Analgesics As with other NSAI
Page 7: Piroxicam inhibits prostaglandin sy

BREXIN

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